MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that on (b)(6) 2007, patient was admitted to the facility where the surgeon performed spine fusion surgery using rhbmp2 on the lumbar region of his spine from vertebrae l3 to s1.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, patient reported to have "increasingly severe low back pain and radiculopathy"."severe pain and symptoms ultimately let the patient to undergo a revision surgery on (b)(6) 2012.Patient reportedly "continues to experience constant lower back pain, with pain radiating down to his hips and legs, and numbness and tingling in his back.Patient experiences difficulty sitting, standing and walking".Patient "requires use of a quell for his leg pain and daily use of a back brace".Patient also "suffers from extreme loss of physical mobility and ability to be active, and erectile dysfunction".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6)2007, the patient was pre-operatively diagnosed with 1) grade i spondylolisthesis at l3-l4 with severe spinal stenosis.2) severe degenerative disc disease at l3-l4, l4-l5, and l5-s1.3) left l5-s1 foraminal stenosis and underwent the following procedures: 1) anterior lumbar discectomies l3-l4, l4-l5, and l5-s1 following anterior retriperitoneal exposure.2) anterior lumbar interbody fusion l3-l4, l4-l5, and l5-s1 using carbon fiber cages packed with rhbmp-2 and ossature granules.3) placement of anterior lumbar blocking screws l3-l4, l4-l5, and l5-s1 using 6.5 titanium cancellous screws of 25mm in length.As per op-notes,¿ initially the l3-l4 disk was exposed and marked with a needle and confirmed radiographically.A box annulotomy was performed.Contents of the disk were removed back to the pll.The pll was left intact to minimize the risk of over distraction.Attention was then turned to the fusion.A carbon fiber cage, which was 14 mm height and 10 degrees angled in lordosis was selected.This was a medium size implant.This was packed with rhbmp-2 sponges and ossature granules.This was impacted into the disk space at an appropriate depth after the endplates had been curetted.¿ the patient tolerated the procedure well without any intraoperative complications.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6025069
• MDR Text Key: 57250451
• Report Number: 1030489-2016-02867
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 01/08/2018
• Supplement Dates FDA Received: 09/25/2017; 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention